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. 2019 Sep 4;2019(9):CD005049. doi: 10.1002/14651858.CD005049.pub5

Summary of findings 8. Dronedarone compared to placebo or no treatment for maintaining sinus rhythm after cardioversion of atrial fibrillation.

Dronedarone compared to placebo or no treatment for maintaining sinus rhythm after cardioversion of atrial fibrillation
Patient or population: adults in sinus rhythm after cardioversion of atrial fibrillation
 Setting: hospital/community
 Intervention: dronedarone
 Comparison: placebo or no treatment
Outcomes Anticipated absolute effects* (95% CI) Relative effect
 (95% CI) № of participants
 (studies) Certainty of the evidence
 (GRADE) Comments
Risk with placebo or no treatment Risk with dronedarone
All‐cause mortality
 follow‐up: range 6–12 months Study population RR 0.86
 (0.68 to 1.09) 6071
 (3 RCTs) ⊕⊕⊕⊕
 High
51 per 1000 44 per 1000
 (35 to 56)
Withdrawals due to adverse effects
 follow‐up: range 6–12 months Study population RR 1.58
 (1.34 to 1.85) 6071
 (3 RCTs) ⊕⊕⊕⊝
 Moderatea
77 per 1000 122 per 1000
 (104 to 143)
Proarrhythmia
 follow‐up: mean 12 months Study population RR 1.95 (0.77 to 4.98) 5872
 (2 RCTs) ⊕⊕⊕⊝
 Moderateb
18 per 1000 36 per 1000
 (14 to 91)
Stroke
 follow‐up: mean 12 months Study population RR 0.66
 (0.47 to 0.95) 5872
 (2 RCTs) ⊕⊕⊕⊕
 High
27 per 1000 18 per 1000
 (13 to 25)
Recurrence of atrial fibrillation
 follow‐up: range 6–12 months Study population RR 0.85
 (0.80 to 0.91) 1443
 (2 RCTs) ⊕⊕⊕⊝
 Moderatec
76.6 per 100 65.1 per 100
 (61.3 to 69.7)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidenceHigh certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
 Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
 Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
 Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded one level for study limitations: 83% of weight came from a study with unclear blinding, which could be relevant to this outcome.
 bDowngraded one level for inconsistency due to very high I2 statistic of 78%.
 cDowngraded one level for study limitations: most weight came from a study with unclear allocation concealment.